Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

M3536A HeartStart MRx with Wireless Link Upgrade (861289) The HeartStart Recalled by Philips Medical Systems, Inc. Due to Wireless Link may be unable to transmit data...

Date: February 18, 2014
Company: Philips Medical Systems, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Philips Medical Systems, Inc. directly.

Affected Products

M3536A HeartStart MRx with Wireless Link Upgrade (861289) The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.

Quantity: 220 devices

Why Was This Recalled?

Wireless Link may be unable to transmit data when configured for a specific data flow.

Where Was This Sold?

This product was distributed to 22 states: AZ, CA, FL, IL, IN, KS, KY, MD, MA, MI, MN, MO, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA

Affected (22 states)Not affected

About Philips Medical Systems, Inc.

Philips Medical Systems, Inc. has 65 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report